NCT06423196

Brief Summary

Introduction. Blood flow restriction therapy involves the use of an occlusion cuff placed over an extremity resulting in a partial reduction of arterial blood flow and total restriction of venous return. Objectives. To analyse the efficacy of a physiotherapy intervention using blood flow restriction in improving upper limb strength in adult handball players. Methods. Randomised, single-blind, clinical study. 20 athletes will be recruited and randomly assigned to the experimental and control groups. The intervention of the experimental group will consist of performing an exercise protocol after blood flow restriction. The intervention period will last 4 weeks, with a periodicity of 2 weekly sessions of 30 minutes each. The primary variable will be the strength of the triceps, epicondyle and epitrochlear musculature (pressure hand dynamometer). The secondary variable will be the muscle activation of this musculature (surface electromyography).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

May 19, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2024

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2024

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

March 25, 2025

Status Verified

May 1, 2024

Enrollment Period

27 days

First QC Date

May 15, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

HandballBlood flow restrictionMuscle strengthMuscle activationUpper limbsPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Assess the muscle strength at screening visit

    Muscle strength will be assessed with a pressure dynamometer (Lafayette Manual Muscle model). The strength of the triceps brachii, epicondyle and epitrochlear musculature will be measured. The evaluation protocol used by Morin et al. will be used. The unit of measurement is the Newton (the higher the value, the greater the muscle strength). The measurements are taken bilaterally. The mean value of the 2 measurements taken shall be used as a measure.

    Screening visit, within the first seven days after treatment and after four weeks follow-up

Secondary Outcomes (1)

  • Assess the muscle activation at screening visit

    Screening visit, within the first seven days after treatment and after four weeks follow-up

Study Arms (2)

Experimental group

EXPERIMENTAL

The intervention of the experimental group will consist of performing an exercise protocol after carrying out the blood flow restriction. A total of 6 muscle strength exercises will be performed for the proximal (triceps brachii) and forearm (epitrochlear and epicondylar muscles).

Other: Experimental group

Control group

NO INTERVENTION

Patients included in the control group will continue with their pre-study training and activities, without modifying their routine.

Interventions

In the development of the exercises, the players will mobilise dumbbells of different weights that will be estimated according to the calculation of 30% of 1 RM. This workload with dumbbells is based on previous work where blood flow restriction was used in healthy athletes.

Experimental group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Athletes over 18 years of age.
  • Federated in handball at the time of the study.
  • No lower limb injuries in the three months prior to the study.
  • Signing the informed consent document.

You may not qualify if:

  • Athletes who have undergone surgery in the year prior to the study.
  • People who do not attend at least 80% of the treatment sessions.
  • Players who are receiving physiotherapy treatment in parallel to the physical preparation of the team they are playing for.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Católica San Antonio, Murcia

Murcia, 30107, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Three assessments will be made throughout the study: before the intervention (T0), after the experimental phase (T1) and after a 4-week follow-up period (T2). All variables will be assessed by an evaluator blinded to the assignment of the athletes to the study groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 15, 2024

First Posted

May 21, 2024

Study Start

May 19, 2024

Primary Completion

June 15, 2024

Study Completion

July 1, 2024

Last Updated

March 25, 2025

Record last verified: 2024-05

Locations